# K260879: 4DM

- Pathway: 510(k) (Traditional)
- Applicant: Invia, LLC
- Decided: Sep 10, 2026 after 177 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101279: CORRIDOR4DM V2010 Model: V2010, Invia (2010) Summary page 7.

## Indications for use
4DM is a software application used by medical professionals to analyze and report nuclear medicine, PET, CT, MR and hybrid patient studies to support their assessment of a patient's cardiac health. 4DM provides tools to process, review, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. 4DM software performs quantification and enables: • Assessment of Cardiac Function with Nuclear Myocardial Perfusion Imaging o Quantify ventricular function (e.g. volumes, ejection fraction , diastolic) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. o Quantify regional ventricular function (e.g. wall motion, thickening, contractility) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. • Assessment of Cardiac Function with Nuclear Gated Blood Pool Imaging o Quantify ventricular volumes and the ejection fraction (EF) from gated ECT blood pool images. o Quantify ejection fraction (EF) from planar gated blood pool images. • Assessment of Myocardial Perfusion with Nuclear Myocardial Perfusion Imaging o Quantify regional relative myocardial perfusion with comparison to normal limits for interpretation of perfusion abnormalities by the Clinician. o Provide semi-quantitative segmental myocardial perfusion scoring using standard segmental overlay(s). o Quantify transient ischemic dilation from stress-rest myocardial perfusion images. • Assessment of Myocardial Blood Flow with Nuclear Cardiology Imaging o Quantify and display myocardial blood flow and flow reserve from SPECT or PET dynamic sequences. • Assessment of Myocardial Viability with Nuclear Cardiology Imaging o Quantify regional perfusion and metabolic radiotracer uptake for the interpretation of viable myocardium by the Clinician. • Assessment of Inflammation and Infection with Nuclear Cardiology Imaging o Quantify regional radiotracer uptake for the review and interpretation of the presence of inflammation and infection in the heart and body by the Clinician. • Assessment of Cardiac Coronary Calcium with CT Imaging o Quantify the presence of calcium in the coronary vessels for review and interpretation by the Clinician. • SPECT Image Reconstruction o Motion correction of SPECT tomographic projection images for patient or organ motion. o Image reconstruction of SPECT tomographic projection images with post reconstruction filtering and reorientation. 4DM shall be used by qualified medical professionals. It does not provide diagnoses or therapeutic recommendations but is instead a visual and quantitative aid.

Source page: https://510kreport.com/device/K260879
Methodology: https://510kreport.com/methodology